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The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study (RAAS-PARC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01691781
First received: September 20, 2012
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
This study will evaluate whether commonly used blood pressure medications called "ACE inhibitors" can lower parathyroid hormone.

Condition Intervention
Hyperparathyroidism
Drug: captopril
Drug: Lisinopril

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: The Renin-Angiotensin-Aldosterone System and Parathyroid Hormone Control: The RAAS-PARC Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Parathyroid hormone, before and after, ACE inhibitor administration [ Time Frame: Initiation of study and after 1 week of ACE inhibitor administration ]

Secondary Outcome Measures:
  • Serum and urinary aldosterone measurements before and after ACE inhibitor use [ Time Frame: On initiation of the study, and after 1 week of ACE inhibitor administration ]
  • Serum calcium before and after ACE inhibitor administration [ Time Frame: On initiation to the study and after 1 week of ACE inhibitor use ]

Enrollment: 41
Actual Study Start Date: October 2012
Study Completion Date: December 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lisinopril
Lisinopril - open-label, 2.5-40mg daily
Drug: captopril
At the initial visit, each subject will receive a single dose of captopril, with blood measurements before and 1-2 hours, after the dose.
Drug: Lisinopril
Each subject will receive one week of lisinopril and return for repeat for blood measurements.

Detailed Description:

The RAAS-PARC study will evaluate whether angiotensin-converting enzyme inhibitors (ACEi) can lower parathyroid hormone (PTH) in normal controls and in individuals have a diagnosis of primary hyperparathyroidism.

Emerging data has implicated the renin-angiotensin-aldosterone system (RAAS) activity with increased PTH. The principal investigator, and other investigators, have previously shown that inhibiting the RAAS may lower PTH. The current study will focus on:

  1. Normal Physiology: Does an ACEi (which lowers angiotensin II and aldosterone) reduce PTH in normal individuals?
  2. Pathophysiology: Does an ACEi reduce PTH in individuals with primary hyperparathyroidism?

The results of this study may have important implications for cardiovascular and skeletal health, as both the RAAS and PTH have been implicated as mediators of these conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects with with no medical problems (n=15) and individuals with primary hyperparathyroidism (n=30)
  • normal blood pressure or stage 1 hypertension that is either untreated, or adequately treated with a single anti-hypertensive medication.
  • Age >18 years and <80 years
  • Estimated GFR > 60ml/min

Exclusion Criteria:

  • Chronic Kidney Disease or eGFR<60
  • Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
  • Type 2 Diabetes Mellitus that is not controlled by diet or Metformin alone or with a Hemoglobin A1c >7.5%
  • History of liver failure
  • History of heart failure
  • The use of typical or atypical antipsychotic medications or lithium.
  • Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs or glucocorticoids
  • The use of prescribed doses of potassium supplements.
  • Illness requiring overnight hospitalization in the past 6 months
  • Active tobacco or recreational drug use
  • Pregnancy or current breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691781

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Anand Vaidya, MD, MMSc Brigham and Women's Hospital, Harvard Medical School
  More Information

Responsible Party: Anand Vaidya, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01691781     History of Changes
Other Study ID Numbers: 2012p0001961
Study First Received: September 20, 2012
Last Updated: March 20, 2017

Keywords provided by Brigham and Women's Hospital:
Hyperparathyroidism
Renin-angiotensin-aldosterone system
ACE inhibitors

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Lisinopril
Captopril
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents

ClinicalTrials.gov processed this record on April 28, 2017